Purpose

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males or Females age 18 to 70 years old
  • Onset of hypersomnia between age 10 and 30 years of age
  • An Epworth Sleepiness Scale score of greater than or equal to 11
  • Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial)
  • Females with a negative pregnancy test AND who are non-lactating
  • Sexually active females of childbearing potential must be willing to use a highly effective method of birth control
  • Sexually active males must have a vasectomy or use condoms

Exclusion Criteria

  • History of any disorder causing hypersomnia other than IH
  • Evidence of circadian-rhythm disorder
  • Sleep apnea syndrome
  • Use of CPAP
  • Obese subjects with BMI greater than or equal to 35kg/m2
  • History of or current seizure disorder or history of syncope, unexplained loss of consciousnesses or seizure in the past 3 years as well as any past history of benzodiazepine and/or barbiturate and/or alcohol-related withdrawal seizures
  • Columbia-Suicide Severity Rating Scale (C-SSRS) findings consistent with significant history of or current suicidal ideation or behavior
  • Subjects who fail to wash out medications for IH or any other prohibited medications
  • Positive toxicology screen test during the Screening or Baseline Visits.
  • Clinically significant abnormal findings from physical, electrocardiogram (ECG) or laboratory assessments at Screening
  • History of or current significant pulmonary, cardiac, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carinomas or local cervical squamous cell carcinoma resolved after resection) or hypothyroidism (unless euthyroid at Screening Visit and treated with a stable dose of medication for at least 3 months prior to the Baseline Visit).
  • Participation in a clinical drug trial within 4 weeks of Screening Visit

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Subject Receives BTD001 first
  • Drug: Pentetrazol (PTZ)
    BTD-001 is an oral capsule of PTZ.
    Other names:
    • PTZ
  • Drug: Placebo oral capsule
    Placebo will be presented as oral capsule.
Experimental
Subject Receives Placebo first
  • Drug: Pentetrazol (PTZ)
    BTD-001 is an oral capsule of PTZ.
    Other names:
    • PTZ
  • Drug: Placebo oral capsule
    Placebo will be presented as oral capsule.

Recruiting Locations

Albert Einstein College of Medicine
New York, New York 10467
Contact:
718-920-2880
mfiguera@montefiore.org

More Details

Status
Recruiting
Sponsor
Balance Therapeutics

Study Contact

Nichole Baio
650-351-7677
nichole.baio@balance-therapeutics.com

Detailed Description

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia (IH). The objectives of this study are two-fold: 1) To evaluate the efficacy of BTD-001 in subjects with IH as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) To characterize the safety and tolerability of oral BTD-001 administered to subjects with IH.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.